Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 3

Equipment Identification with respect to GMP

• Are all pieces of equipment clearly identified with easily visible markings? Check here YES / NO
• Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log? Check here YES / NO
• Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance? Check here YES / NO
• Is the maintenance log for each piece of equipment kept on or near the equipment? Check here YES / NO

Equipment Maintenance & Cleaning with respect to GMP

• Are written procedures established for the cleaning and maintenance of equipment and utensils? Check here YES / NO
• Are these procedures followed? Check here YES / NO
• Does a written procedure assign responsibility for the cleaning and maintenance of equipment? Check here YES / NO
• Has a written schedule been established and is it followed for the maintenance and cleaning of equipment? Check here YES / NO
• Has the cleaning procedure been properly validated? with respect to who GMP guide for quality assurance .Check here YES / NO
• If appropriate, is the equipment sanitized using a procedure written for this task? Check here YES / NO
• Has a sufficiently detailed cleaning and maintenance procedure been written for each different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance? Check here YES / NO
• Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?
• Is equipment cleaned promptly after use? IS GMP FOLLOWED Check here YES / NO
• Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment? Check here YES / NO
• Is clean equipment adequately protected against contamination prior to use? Check here YES / NO
• Is equipment inspected immediately prior to use? Check here YES / NO
• Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment? Check here YES / NO

Measurement Equipment Calibration Program for GMP

• Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.) Check here YES / NO
• Are records of calibration checks and inspections maintained in a readily retrievable manner? Check here YES / NO

Equipment Qualification Program for GMP

• Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results. Check here YES / NO
• When computers are used to automate production or quality testing, have the computer and software been validated? Check here YES / NO
• Have on-site tests of successive production runs or tests been used to qualify equipment? Check here YES / NO
• Were tests repeated a sufficient number of times to ensure reliable results? Check here YES / NO
• Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results? Check here YES / NO
• Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.) Check here YES / NO
• Have operating limits and tolerances for performance been established from performance characteristics? Check here YES / NO

Material/Component Specification and Purchasing Control

• Although purchasing is not specifically addressed in the current GMP regulation, incumbent upon user of components and materials to ensure quality of product, material or component. Check here YES / NO
• Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls? (Review suppliers and audits and enter names, material supplied, and date last audited in notebook.) Check here YES / NO
• Material/Component Receipt, Inspection, Sampling, and Laboratory Testing Check here YES / NO
• Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.) Check here YES / NO
• Is each lot within each shipment of material or components assigned a distinctive code so material or component can be traced through manufacturing and distribution? Check here YES / NO
• Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination? Check here YES / NO
• Is the number of representative samples taken from a container or lot based on statistical criteria and experience with each type of material or component?
• Is the sampling technique written and followed for each type of sample collected? Check here YES / NO
• Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required? Check here YES / NO
• Verify that the following steps are included in written procedures unless more specific procedures are followed:Containers are cleaned before samples are removed. Check here YES / NO
• Stratified samples are not composited for analysis. Check here YES / NO
• Containers from which samples have been taken are so marked indicating date and approximate amount taken. Check here YES / NO
• Each sample container is clearly identified by material or component name, lot number, date sample taken, name of person taking sample, and original container identification. Check here YES / NO
• At least one test is conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA. Check here YES / NO

• If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a written protocol to determine suitability for purpose. 
• Microbiological testing is conducted where appropriate. Check here YES / NO
  Reference : WHO guideline for GMP/Internet